Parathyroid hormone, together with calcitonins and vitamin Ds, is a hormone that participates in regulating the calcium concentration in the blood. Therefore, PTH peptide is used as a diagnostic for hypoparathyroidism. Parathyroid hormone is also known to accelerate the absorption of calcium in the intestine by increasing active vitamin D3 production in the kidneys (Non-patent Reference 1). A method of treating osteoporosis that increases the density of cancellous bone and does not decrease the density of the cortical bone of osteoporosis patients by subcutaneous administration of 100 or 200 units/time of PTH once a week over a period of 26 weeks to osteoporosis patients has also been disclosed (Patent Reference 7).
A method of combining mannitol or another such saccharide or gelatin or another such macromolecular substance as a stabilizer is generally used when making a trace of PTH peptide into a freeze-dried preparation to be dissolved at the time of use (Patent References 1 and 2). A freeze-dried pharmaceutical composition characterized in containing a monosaccharide or disaccharide and sodium chloride is also known (Patent Reference 3).
When a freeze-dried preparation such as the above is manufactured aseptically to produce a pharmaceutical, ordinary pharmaceutical production facilities utilize areas that achieve a sterile environment by a stream of aseptic air of a constant speed that has passed through HEPA filters. A manufacturing process in a pharmaceutical production facility under this sterile environment typically consists of a step for preparing an active ingredient solution, followed by a step for aseptically filtering of the solution and dispensing it into containers, a step for loading the filled containers into a freeze-drying chamber, and a step for sealing the containers (vials and the like) after the freeze-drying step.